R-SI-LINE ® METAL-BITE ®
- Primary DI
- ERDEMBK10741
- Brand
- R-SI-LINE ® METAL-BITE ®
- Company
- R-Dental Dentalerzeugnisse GmbH
- Model
- MBK1074
- Catalog number
- MBK1074
- Device description
- METAL-BITE ® is an universal registration material on vinyl polysiloxane base (addition curing, VPS). METAL-BITE ® is extremely fast, hard and thixotropic. It is easy to trim, very suitable for cutting and contouring. The material has no taste at all, is radiopaque and offers an excellent dimension stability. Further on METAL-BITE ® is predestined for bite plate applications of the facebow registration system and for manufacturing surgical guides for implantology. It is used successfully for the fit of para-occlusal tray adapters in CMD. METAL-BITE ® was introduced in early 2000 and has earned several awards of excellence from Reality and The Dental Advisor from 2012 to 2016. METAL-BITE ® is marketed worldwide. The product is available in standard 50 ml auto-mixing cartridges plus 12 mixing cannulas and can be dispensed with a commercial dispenser.
- Published
- 2016-09-24
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes
| Code | Name |
|---|
| ELW | Material, Impression |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| ELW | Material, Impression | Dental | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| ERDEMBK10741 | Primary | HIBCC | 0 | |
| CARTRIDGES2 | Unit of Use | HIBCC | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Silicone dental impression material | An elastomeric, polysiloxane-based material capable of reacting to form a rubber-like substance suitable to reproduce the structure of a patient's teeth and gums, or other oral anatomy, after being placed on an impression tray and inserted into the mouth. This is a single-use device. |
Storage And Handling
| Type | Low | High | Condition |
|---|
| Handling Environment Temperature | 4 Degrees Celsius | 25 Degrees Celsius | |
Contacts
| Phone | Email |
|---|
| +4940307070730 | info@r-dental.com |
Regulatory Flags
- DUNS number
- 313956880
- Device count
- 2
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- true
- Combination product
- false
- Lot or batch
- true
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|
| ERDEKMK10881 | KwikkModel ® SCAN | KMK1088 | KMK1088 | 2016-09-24 |
| ERDEMBK04751 | R-SI-LINE ® METAL-BITE ® Blue | MBK0475 | MBK0475 | 2016-09-24 |
| ERDEMBK07501 | R-SI-LINE ® METAL-BITE ® GOLD | MBK0750 | MBK0750 | 2016-09-24 |
| ERDEMOK04751 | R-SI-LINE ® MONO S SCAN | MOK0475 | MOK0475 | 2016-09-24 |
Other Devices Sharing Product Codes
r-dental.com